FDA product code GQI: Antiserum, Cf, Cytomegalovirus
GQI is the FDA product code for antiserum, cf, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under GQI, from 14 different applicants. The average 510(k) review took 217 days (median 164).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GQI clearance
Top GQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pyramid Biological Corp. | 2 | 1995-11-16 |
| Gull Laboratories, Inc. | 2 | 1988-05-06 |
| Labsystems, Inc. | 2 | 1986-10-01 |
| Amico Lab, Inc. | 2 | 1985-12-06 |
| Neogenex | 1 | 1994-06-30 |
9 more applicants have GQI clearances. See the full list in Caduvo.
Most recent GQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951800 | Pyramid Biological Corp. | CMV IGG HUMAN SERUM CONTROLS | 1995-11-16 | 212 |
| K952254 | Pyramid Biological Corp. | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 1995-11-16 | 185 |
| K942171 | Neogenex | CMV EARLY ANTIGEN TEST | 1994-06-30 | 56 |
| K883102 | Electro-Nucleonics, Inc. | VIRGO (R) CMV-IGG ELISA | 1989-02-08 | 201 |
| K875159 | Gull Laboratories, Inc. | DETECTADOT SYSTEM 2000 CMV IGG TEST | 1988-05-06 | 142 |
Recalls for GQI devices
openFDA lists no recalls for product code GQI.
Frequently asked questions
What is FDA product code GQI?
GQI is the FDA product code for antiserum, cf, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is GQI?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQI?
Across 18 cleared submissions the average was 217 days from receipt to decision (median 164).
Which companies have the most GQI clearances?
Pyramid Biological Corp. (2); Gull Laboratories, Inc. (2); Labsystems, Inc. (2); Amico Lab, Inc. (2); Neogenex (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQI
- Run a recall and safety report across every GQI manufacturer
- Watch product code GQI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times